Kornimate/medical-research-clean huggingface dataset:
sonazoid-enhanced ultrasound for the detection of colorectal liver metastases less than 2 cm

Conditions: Liver Metastasis Colon Cancer

Summary: preoperative chemotherapy is often used for patients with colorectal cancer liver metastasis (clm). many small clms (\<=2cm) may disappear after chemotherapy, while most of these are still alive. ultrasonography (us) is a common imaging modality for the intraoperative detection tumor. sonazoid is new echo-contrast agent, which is more stable and sensitive for detecting of small tumor. investigators initially this prospective study to compare the detection performance before and after using sonazoid.


Eligibility criteria:
inclusion criteria: * pathology confirmed colorectal adenocarcinoma * one or more liver metastases less than 2 cm * multidisciplinary team recommend to perform preoperative chemotherapy * have baseline eob-mr before chemotherapy exclusion criteria: * could not fulfill the criteria of no evidence of disease (ned) after hepatic resection/ablation/radiotherapy * with other malignancies
intermittent ropivacaine bolus for epidural labor analgesia

Conditions: Labor Pain

Summary: enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. epidural analgesia appears to be currently the most effective technique in reducing pain during labor. however, reduction in total dose of local anesthetic and thus motor blockade is crucial to improve the obstetric outcome. this technique has evolved from intermittent boluses by anesthesiologists to the current standard labor epidural analgesic regimens in many institutions in north america and europe that consist of a local anesthetic in combination with an opioid delivered via continuous epidural infusion (cei) with or without patient-controlled epidural analgesia (pcea) boluses. recently,a new mode of administration has been used: regular bolus of low concentration local anesthetic + intermittent bolus (pieb). this technique would offer safe and superior quality labor analgesia and greater maternal satisfaction by reducing total amount of the drug combination. the primary outcome was to evaluate the analgesic efficacy of pieb epidural drug delivery in terms of visual analogue scale satisfaction (vas) score in a large cohort of patients. the secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes, total drug dose and incidence of pain that required top-up administration (breakthrough pain)

patients were explained about the procedure and written informed consent was obtained. healthy term primi or second gravid parturients (aged \>18 years) with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm were recruited in the study after they requested epidural for pain relief. pieb epidural analgesia was used. primary outcome was maternal satisfaction during labor and delivery. our hypothesis was that patients would have a greater level of satisfaction when using pieb technique. the secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes.

Eligibility criteria:
inclusion criteria: * healthy term primi or second gravid parturients * aged 18-30 years * singleton, live fetus * vertex presentation * active stage of labor with cervical dilation of 3-5 cm parturients exclusion criteria: * hypertension * no vertex presentation * contraindications to neuraxial blockade

Keywords: pregnant labor epidural analgesia intermittent
a study of olanzapine in patients with acute agitation

Conditions: Acute Agitation

Summary: the purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar i mania.


Eligibility criteria:
inclusion criteria: 1. male and female patients between the ages of 18 to 65 years, inclusive. 2. patients who have met dsm-5 criteria for schizophrenia and bipolar i disorder. 3. patients who are judged to be clinically acutely agitated with a total score of ≥ 14 on the 5 items comprising the panss-ec and at least one individual item score≥ 4 immediately before randomization. exclusion criteria: 1. patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse. 2. patients who have had previous suicidal behavior or currently at serious risk of suicide. 3. patients with glaucoma or at risk of angle-closure glaucoma. 4. patients who have brain diseases such as intracranial infection, brain trauma, cerebrovascular disease, basal ganglion disease, hypoxic encephalopathy, parkinson's disease, parkinson's syndrome, and dementia. 5. use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization. 6. treatment with psychostimulants or reserpine within one week before randomization. 7. patients who received long-acting injections of typical or atypical antipsychotics within 2 weeks prior to randomization or within one injection interval. 8. treatment with clozapine within 4 weeks before screening. 9. patients with serious or unstable medical illnesses. 10. female patients who have a positive pregnancy test at screening or are breastfeeding. 11. patients who have participated in other clinical trials within 3 months before randomization.
balance and weight distributions at kneeling

Conditions: Balanced; Weight, Body

Summary: this study aims to examine balance parameters and weight distributions at different kneeling positions.

a cross-sectional study design was used to describe the balance parameters and weight-bearing distributions on knee in different kneeling positions with different ankle conditions. the participants signed informed consent forms before the study was performed on a voluntary basis. inclusion criteria were defined as being between 18-30 years old and not having knee pain with kneeling. exclusion criteria were previous history of lower limb pain/pathology, trauma, and/or surgery, any neurological, rheumatological or oncological disorders that would affect balance, have performed high intensity physical activities last 72 hours before test day, and bmi \> 25. balance parameters and weight distribution to each knee were evaluated three times at upright kneeling (uk) and full kneeling (fk) positions, in different ankle conditions (dorsiflexion and plantarflexion) with static balance device. test-retest icc values were calculated for all procedures.

Eligibility criteria:
inclusion criteria: * being between 18-30 years old * not having knee pain with kneeling exclusion criteria: * previous history of lower limb pain/pathology, * trauma, and/or surgery, any neurological, rheumatological or oncological disorders that would affect balance, * have performed high intensity physical activities last 72 hours before test day, * bmi \> 25

Keywords: kneeling weight distribution balance lower extremity asymmetry
hyperthermia enhanced re-irradiation of loco-regional recurrent tumors

Conditions: Recurrent Cancer; Prostate Cancer; Cervical Cancer; Anal Cancer; Sarcoma; Rectal Cancer; Neuroendocrine Tumors; Esophageal Cancer; Pancreas Cancer; Squamous Cell Carcinoma

Summary: this study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.

patients that present a relapse within the previously irradiated volume can be included in this trial. these patients will receive re-irradiation according to clinical guidelines and hyperthermia as study intervention. according to tumor location hyperthermia can either be performed by microwave or by capacitive devices. the primary endpoint of this study is non-inferiority of re-irradiation compared to the initial course of radiotherapy (calculated as time to local failure).

Eligibility criteria:
inclusion criteria: * prior radiotherapy of the treatment side with a treatment dose \> 30 gray (gy) eqd2 (calculated with alpha/beta value of 9) * local/ regional / or oligometastatic tumor recurrence. maximum number of three macroscopic tumor lesions with at least one of them receiving prior radiotherapy * macroscopic tumor recurrence * side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine, cervical lymphnodes) * planned re-irradiation dose of at least 40 gy eqd2 (calculated with alpha/beta value of 9) exclusion criteria: * \>3 macroscopic tumor lesion * brain metastases * recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy) * recurrence region is not amenable to hyperthermia (lung, liver, mediastinum) * contraindications for hyperthermia (serious cariovascular disease, icd or larger implants at the treatment site) * psychiatric disorders that impede proper informed consent * serious comorbidities with very limited prognosis quo ad vitam

Keywords: re-irradiation hyperthermia local recurrence hyperthermic
liver spare the nephron (stn) study - a study of cellcept (mycophenolate mofetil) and sirolimus in recipients of a liver transplant

Conditions: Liver Transplantation

Summary: this two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with cellcept and sirolimus in recipients of an orthotropic liver transplant. patients will be randomized to receive either cellcept 1-1.5 g twice daily (bid) + tacrolimus + cyclosporine, or cellcept 1-1.5 g bid + sirolimus. the anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18-74 years of age * single primary liver transplant from a deceased donor * cellcept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours) * patients with hepatitis c-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. this is not required for patients negative for hepatitis c. exclusion criteria: * liver allograft from a living donor or a split liver * multiple organ transplant * dialysis therapy for \>14 days from transplantation to randomization * history of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer) * previous sirolimus therapy
evaluation of safety and parameters of application technique

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this study is conducted in europe. the aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in slovakia.


Eligibility criteria:
inclusion criteria: * diabetes mellitus (type 1 or type 2) * treated with insulin
instrument assisted soft tissue mobilization versus dry cupping on chronic mechanical neck pain

Conditions: Neck Pain

Summary: which is more effective instrument assisted soft tissue mobilization or dry cupping on pain intensity, cervical range of motion and functional status in patients with chronic mechanical neck pain?

neck pain is a common musculoskeletal pathology treated by physical therapists around the world. neck pain is one of the highest complaints in terms of years lived with a disability, increasing the prelevancy of proper management by physical therapists. the overall prevalence of neck pain ranges from 10% to 20%, and the incidence of new neck pain ranging from 10% to 50%. dry cupping involves the use of glass, plastic or bamboo cups that are placed over localized areas of skin. a vacuum suction is achieved with heat from a flame, a manual handheld pump or electrical pumping devices to create a negative pressure, drawing localized skin and soft tissue structures into the cup . instrument-assisted soft tissue mobilization (iastm) is a new technique, which has been known to be effective in reducing muscle tightness in athletes . iastm is a new tool, which allows clinicians to efficiently locate and treat individuals diagnosed with soft tissue dysfunction . the use of the instrument is thought to provide a mechanical advantage for the clinician by allowing deeper penetration and more specific treatment, while also reducing imposed stress on the hands

Eligibility criteria:
inclusion criteria: * 45 patients with chronic mechanical neck pain in the past 3 months. * age range from 18 to 35 years old. * patients will be from both sexes. * body mass index from 18.5 to 24.9 kg/m2. * subjects suffer from chronic mechanical neck pain. exclusion criteria: * serious injury. * tumor. * infection. * spinal fractures. * recent cervical surgery. * cervical radiculopathy. * skin disease, allergy, hypersensitivity, any malignant or benign tumors. * unhealed scars or wounds. * pregnancy. * known psychiatric condition under treatment or medication. * any orthopedic and neurological condition as cervical pivd, spondylolisthesis.
glpg2737 on top of orkambi in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a phase iia, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate glpg2737 administered orally b.i.d. for 28 days to adult male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the f508del cftr mutation and on stable treatment with orkambi.


Eligibility criteria:
inclusion criteria: * male or female subject ≥18 years of age on the day of signing the icf. * a confirmed clinical diagnosis of cf and homozygous for the f508del cftr mutation. * stable intake of physician prescribed orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.) for at least 12 weeks prior to the first study drug administration, and planned continuation of orkambi for the duration of the study. * fev1 ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator). * sweat chloride concentration ≥60 mmol/l at screening. exclusion criteria: * history of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to any component of the study drug. * history of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator. * unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks prior to the first study drug administration. * history of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices, etc.). * abnormal liver function test at screening, defined as aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) and/or alkaline phosphatase and/or gammaglutamyl transferase (ggt) ≥3 x the upper limit of normal (uln), and/or total bilirubin ≥1.5 x the uln at screening.
inspiratory muscle training for patients with chronic obstructive pulmonary disorder

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study is a randomized controlled trial with the aim of evaluating the effect of homebased inspiratory muscle training (imt) for patients with copd in norway. the intervention group will train with threshold imt for 6 weeks. the control group will not participate in any other training method or sham. evaluation parameters are maximal inspiratory pressure, six minute walk test, copd assessment test, modified medical research council dyspnea scale and spirometry.


Eligibility criteria:
inclusion criteria: * copd grade iii-iv, * inhabitant of hedmark (løten, våler, åsnes, hamar, elverum) exclusion criteria: * undergoing exercise based physical therapy treatment, * not able to do imt physically or mentally
corneal epithelial wound healing difference between human autoserum and cord blood serum

Conditions: Corneal Epithelial Wound Healing

Summary: human serum eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. however, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. the purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, mts assay and boyden chamber migration assay in response to human serum and umbilical cord serum. the concentrations of egf, tgf-β1, and fibronectin were also compared between human serum and umbilical cord serum with elisa kits.


Eligibility criteria:
inclusion criteria: * healthy pregnant women * cesarean section for labor * complete placenta with umbilical cord retained * healthy individual exclusion criteria: * the retained placenta and umbilical cord were not complete * individual with anemia or other hematologic disorder unsuitable for blood donation

Keywords: corneal epithelial wound human autoserum cord blood
letrozole in the treatment of severe and recurrent endometriosis

Conditions: Severe and Recurrent Endometriosis

Summary: endometriosis is a condition in which abnormal growth of tissue histologically resembling the lining of the uterus (endometrium) is present outside of the uterus. this study will investigate the effect of a daily dose of letrozole compared to gnrh is safe and in addition effective in reducing measurable endometriosis lesions and in reducing pain in patients with active endometriosis which were pretreated with gnrh analogs for 2 months.


Eligibility criteria:
inclusion criteria * premenopausal women \> 18 years of age. * laparoscopic and histologically confirmed diagnosis of moderate or severe endometriosis according rasrm-score iii and iv * bmi less than 40 kg/m². * patient is sexually abstinent or using mechanical (condoms, diaphragms) or sterilization methods of contraception and is willing to continue using them throughout the study. * patient is willing and able to comply with study requirements. * written informed consent. exclusion criteria * endometriosis stage i-ii acc. according to rasrm * women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric. * significant abnormalities in the physical or laboratory examination including renal and liver function more than twice the normal range. * patient desires pregnancy for the duration of the study, is pregnant or breast feeding. * gnrh therapy during the last 6 months * use of hormonal contraception, selective estrogen receptor modulators, progestins, estrogens, steroids, or ovulation induction in the 4 weeks prior to inclusion into the study. * untreated abnormal pap smear or other gynecologic condition. * history of venous thrombosis events including deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis. * history of stroke, complicated migraine, or documented transient ischemic attack. * known hypersensitivity to any ingredient of the study medication. * treatment with other aromatase inhibitors * other investigational drugs within the past 30 days and the concomitant use of investigational drugs. * history of non-compliance to medical regimens, and patients who are considered potentially unreliable. additional protocol-defined inclusion / exclusion criteria may apply

Keywords: endometriosis gnrh analog aromataseinhibitor letrozole
severe immune cytopenia registry www.sic-reg.org

Conditions: Immune Thrombocytopenia; Autoimmune Hemolytic Anemia; Evans Syndrome; Primary Immunodeficiency

Summary: prospective registry study for children and young adults with severe immune cytopenias (persisting/chronic immune thrombocytopenia, autoimmune hemolytic anemia, and evans syndrome) to improve the management, facilitate the differential diagnostic work-up, and document the clinical course under various treatments. time points: at inclusion, after 6 months, after 12 months, then yearly up to 4 years after inclusion. no intervention, mere observation and documentation. guided pre-inclusion (differential) diagnostic work-up.

the study aims to improve the management and care of patients with severe immune cytopenias, to identify underlying causes of severe immune cytopenias and to develop a strategy for early treatment stratification based on a standardized diagnostic algorithm, potentially supported by biomarker analyses and (off study) genetic analyses, where clinically indicated. primary goal: rapid detection of underlying causes of severe immune cytopenias with the aid of a structured diagnostic approach and access to a clinical care network of the participating centers, allowing early treatment stratification secondary goals: * collection of data about epidemiology of rare diseases * systemic documentation of response rates to various treatments * identification of biomarkers and modifiers of immune tolerance * collection of data about the usage of novel/experimental therapeutic agents * documentation of physician-reported outcome measures/performance scores * consultation of the caring physicians through a regular sic-reg board there will be no additional venous punctures or investigational time points. at clinical visits around planned study time points, additional blood parameters and stool specimen will be obtained. the current clinical management follows international guidelines, which are summarized in the study documents but do not represent part of the study (no diagnostic or therapeutic investigational arm).

Eligibility criteria:
inclusion criteria: * autoimmune hemolytic anemia (aiha) * evans syndrome (es) * persistent or chronic immune thrombocytopenia (itp; \>6 months after first manifestation) exclusion criteria: * (history of) malignancies * (history of) hematopoietic stem cell transplantation

Keywords: pancytopenia aplastic anemia myelodysplastic syndrome primary immunodeficiency immune dysregulation autoimmune cytopenia
descartes-25 in relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma; Relapse Multiple Myeloma

Summary: this is a phase i/iia dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic mesenchymal stem cell (descartes-25) product secreting a bispecific protein and other proteins in patients with relapsed/refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * 18 years and older' * diagnosed with active r/rmm, who have failed 2 lines of treatment * have measurable disease exclusion criteria: - patients with active plasma cell leukemia

Keywords: myeloma multiple myeloma relapse refactory multiple myeloma